FDA holds Type A meeting with Atara after CRL issued for tabelecleucel in EBV-positive PTLD

The FDA and Atara Biotherapeutics met in a Type A meeting to discuss the complete response letter (CRL) that the agency issued for the biologics license application of tabelecleucel, a therapy for EBV-positive, relapsed/refractory post-transplant lymphoproliferative disease (PTLD).

In the meeting, Atara indicated it will provide an updated data set that adds more patients and longer follow-up from the ALLELE trial, along with additional supportive data, to address the FDA’s concerns.

The company expects to submit the revised package later this year, with a further regulatory update projected for the third quarter of 2026.